Trial Outcomes & Findings for Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT) (NCT NCT03881852)
NCT ID: NCT03881852
Last Updated: 2023-08-24
Results Overview
Presented as LSmeans. A positive change is indicative of improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
2 weeks
Results posted on
2023-08-24
Participant Flow
Crossover Design: Subjects meeting the entry criteria will be randomized in a 1:1 ratio either to Sequence 1 \[AXS-12 (up to 10 mg daily) for three weeks followed by placebo for three weeks\] or Sequence 2 \[placebo for three weeks followed by AXS-12 (up to 10 mg daily) for three weeks\].
Participant milestones
| Measure |
Sequence 1
Sequence 1 - AXS-12 (reboxetine) for three weeks followed by placebo for three weeks
|
Sequence 2
Sequence 2 - Placebo for three weeks followed by AXS-12 (reboxetine) for three weeks
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
Dosed With AXS-12
|
11
|
10
|
|
Overall Study
Dosed With Placebo
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)
Baseline characteristics by cohort
| Measure |
Sequence 1
n=11 Participants
Sequence 1 - AXS-12 (reboxetine) for three weeks followed by placebo for three weeks
|
Sequence 2
n=10 Participants
Sequence 2 - Placebo for three weeks followed by AXS-12 (reboxetine) for three weeks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
32.9 years
STANDARD_DEVIATION 6.74 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 9.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPresented as LSmeans. A positive change is indicative of improvement.
Outcome measures
| Measure |
AXS-12 (Reboxetine)
n=21 Participants
AXS-12 (Reboxetine): Dosed orally, twice daily for up to 3 weeks
|
Placebo
n=20 Participants
Placebo: Dosed orally, twice daily for up to 3 weeks
|
|---|---|---|
|
Change From Baseline in the Weekly Average Total Number of Cataplexy Attacks
|
13.0 weekly cataplexy attacks
Standard Error 3.5
|
-0.28 weekly cataplexy attacks
Standard Error 3.5
|
Adverse Events
AXS-12 (Reboxetine)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AXS-12 (Reboxetine)
n=21 participants at risk
Adverse events collected while subjects were in the AXS-12 (reboxetine) period of either Sequence 1 or Sequence 2.
|
Placebo
n=20 participants at risk
Adverse events collected while subjects were in the Placebo period of either Sequence 1 or Sequence 2.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
19.0%
4/21 • Number of events 4 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
19.0%
4/21 • Number of events 4 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
0.00%
0/20 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Psychiatric disorders
Insomnia
|
19.0%
4/21 • Number of events 4 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
9.5%
2/21 • Number of events 2 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
0.00%
0/20 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Psychiatric disorders
Depression
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Immune system disorders
Allergy to animal
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the randomization visit through 7 days after the last dosing date for non-serious AEs and 30 days after the last dosing for serious AEs.
Safety Population includes all subjects who received study drug.
|
Additional Information
Caroline Streicher, Executive Director, Clinical Operations
Axsome Therapeutics, Inc.
Phone: 212-332-5061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place